When new drugs are launched, physicians must have access to the randomized controlled trials that evaluated their efficacy and safety.
I wrote to 12 Canadian pharmaceutical companies, all subsidiaries of multinational companies, who released a total of 16 new drugs from 1990 to 1999. I asked them to supply me with a list of the randomized controlled trials on the primary indication for each product that were published in English and that were available to physicians at the time the product was first marketed in Canada. A second letter was sent to all companies that did not respond after 5 weeks.
Two of the 12 companies did not respond and one said it was unable to compile the necessary data. Of the others, only GlaxoSmithKline accurately complied with my request, sending material on one study for one of its products (it was asked to provide information on 3 products in total). Other companies sent extraneous material, including studies that had been published in other languages, studies published after the product had been marketed and studies evaluating uses of the product other than that for which it was primarily marketed. Interested readers can contact me for a complete list of these studies and drugs. This variability in the responsiveness of pharmaceutical companies is not a new phenomenon.1
All of the companies in question are members of Canada's Research-Based Pharmaceutical Companies (Rx&D). Although neither the Code of Advertising Acceptance2 of the Pharmaceutical Advertising Advisory Board nor Rx&D's Code of Marketing3 covers requests from health care professionals for information not connected with advertising and promotion, such information can be vital to the physicians to whom these new drugs are being marketed.
I strongly urge Canadian pharmaceutical companies to make available to practising physicians the reports of all randomized controlled trials on new drugs being marketed in Canada, at the time of the Canadian launch. They could easily do this by placing the information on their Web sites. If the companies won't do this voluntarily, then the matter should be regulated through a change to the Food and Drugs Act.
Joel Lexchin Emergency Physician University Health Network Toronto, Ont.
References
- 1.Thomas M, Lexchin J. Pharmaceutical manufacturers' responsiveness to physicians' requests for information: a comparison of brand and generic complaints. Soc Sci Med 1990;31:153-7. [DOI] [PubMed]
- 2.Pharmaceutical Advertising Advisory Board. Code of advertising acceptance. Pickering (ON): The Board; 2000. Available: www.paab.ca/code_en.html (accessed 2002 Mar 22).
- 3.Canada's Research-Based Pharmaceutical Companies. Code of marketing. Ottawa: Canada's Research-Based Pharmaceutical Companies; 1999. Available: www.canadapharma.org/en/publications/code/index.html (accessed 2002 Mar 22).